BTMClass II
Ventilator, Emergency, Manual (Resuscitator)
21 CFR 868.5915 / Anesthesiology
BTM is the FDA product code for Ventilator, Emergency, Manual (Resuscitator), a class II device type, regulated under 21 CFR 868.5915. As of , FDA records hold 209 510(k) clearances under this code, the most recent dated , and 97 recalls.
Classification record
- Product code
- BTM
- Device name
- Ventilator, Emergency, Manual (Resuscitator)
- Regulation
- 21 CFR 868.5915
- Device class
- Class II
- Review panel
- Anesthesiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- Yes
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 209
- Ingested recalls
- 97
Clearances, product code BTM
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 3 |
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 4 |
| 1983 | 6 |
| 1984 | 10 |
| 1985 | 5 |
| 1986 | 3 |
| 1987 | 5 |
| 1988 | 16 |
| 1989 | 6 |
| 1990 | 14 |
| 1991 | 14 |
| 1992 | 12 |
| 1993 | 11 |
| 1994 | 6 |
| 1995 | 7 |
| 1996 | 11 |
| 1997 | 9 |
| 1998 | 7 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 7 |
| 2003 | 3 |
| 2004 | 6 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 2 |
| 2008 | 3 |
| 2010 | 2 |
| 2011 | 2 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2025 | 2 |
Applicants with the most clearances
Product code BTM| Applicant | Clearances |
|---|---|
| Medtronic, Inc. | 16 |
| Medical Marketing Concepts | 11 |
| Ambu, Inc. | 10 |
| Life Design Systems, Inc. | 7 |
| Engineered Medical Systems, LLC | 6 |
| Life Support Products, Inc. | 6 |
| Vital Signs, Inc. | 6 |
| Respironics, Inc. | 5 |
| Allied Medical LLC | 4 |
| Ambu, Inc. | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.